Transcatheter delivery systems and delivery catheters for prosthetic mitral valve delivery, and methods for prosthetic mitral valve delivery using a retrograde approach

Patent metadata

Field	Value
Publication number	US-11617649-B2
Application number	US-202016903484-A
Country	US
Kind code	B2
Filing date	Jun 17, 2020
Priority date	Jan 20, 2017
Publication date	Apr 4, 2023
Grant date	Apr 4, 2023

Abstract

Transcatheter delivery systems, delivery catheters and associated methods for percutaneous delivery of prosthetic mitral valves using a retrograde approach are disclosed herein. A heart valve delivery system configured in accordance herewith includes a delivery catheter having an elongated tubular component and an articulation assembly at a distal end thereof. The articulation assembly includes an arm portion coupled to the tubular component by an elbow or hinge portion. In a closed, delivery state, the elbow portion positions the arm portion generally parallel to the tubular component for delivery of the delivery catheter through the vasculature. In an open, deployed state, the elbow portion positions the arm portion in a non-axial direction with respect to a longitudinal axis of the tubular component for orienting and positioning a prosthetic valve device carried by the arm portion, e.g., within the native mitral valve region.

First claim

What is claimed is:

1. A method of deploying a mitral valve prosthesis, the method comprising:
advancing a delivery catheter through an aortic arch in a retrograde manner, the delivery catheter including an articulation assembly having a movable arm portion, wherein during the advancing of the delivery catheter the articulation assembly is in a closed state in which the arm portion is substantially parallel to a longitudinal axis of the delivery catheter with the mitral valve prosthesis being releasably attached to the arm portion;
positioning the articulation assembly in the left ventricle downstream of a native mitral valve;
transitioning the articulation assembly from the closed state to an open state in which the arm portion is angled away from the longitudinal axis of the delivery catheter;
positioning the arm portion and the mitral valve prosthesis releasably attached thereto within the native mitral valve; and
deploying the mitral valve prosthesis within the native mitral valve.

2. The method of claim 1 , wherein the articulation assembly includes an elbow portion having a shape-memory to bias the arm portion into the open state.

3. The method of claim 2 , wherein a distal component of the delivery catheter includes a recess that receives the elbow portion therein to constrain the arm portion when the articulation assembly is in the closed state, and
wherein transitioning the articulation assembly from the closed state to the open state includes distally advancing the distal component to release the arm portion and allow the arm portion to return to the open state.

4. The method of claim 1 , wherein when the articulation assembly is in the closed state, an elbow portion of the articulation assembly is in a state of flexion in which an extension angle formed between the arm portion and the delivery catheter is substantially 0 degrees.

5. The method of claim 4 , wherein when the articulation assembly is in the open state, the elbow portion is in a state of extension and positions the arm portion in an outwardly angled direction with respect to the longitudinal axis of the delivery catheter.

6. The method of claim 5 , wherein in the state of extension, the extension angle formed between the arm portion and the delivery catheter is less than 90 degrees.

7. The method of claim 5 , wherein the elbow portion includes a bellows connector having concertinaed sides, and wherein the elbow portion transitions between the state of flexion and the state of extension hydraulically.

8. The method of claim 5 , wherein the elbow portion is a hinged joint, and wherein advancement of a wire relative to a remainder of the delivery catheter angles the arm portion away from the delivery catheter to transition the elbow portion from the state of flexion to the state of extension.

9. The method of claim 5 , wherein the elbow portion includes a shape-memory to bias the arm portion into the open state.

10. The method of claim 9 , wherein the delivery catheter further includes a tether device attached to the arm portion that restrains the arm portion in the closed state and wherein transitioning the articulation assembly from the closed state to an open state includes actuation of the tether device to allow the arm portion to return to the open state.

11. The method of claim 9 , wherein the delivery catheter further includes a distal tip that restrains the arm portion in the closed state and wherein transitioning the articulation assembly from the closed state to an open state includes distally advancing the distal tip to release the arm portion and allow the arm portion to return to the open state.

12. The method of claim 1 , wherein positioning the arm portion and the mitral valve prosthesis releasably attached thereto within the native mitral valve includes actuating a steering mechanism of the delivery catheter, the steering mechanism including a pull wire.

13. The method of claim 1 , wherein positioning the arm portion and the mitral valve prosthesis releasably attached thereto within the native mitral valve includes distally advancing or proximally retracting the delivery catheter.

14. The method of claim 1 , wherein positioning the arm portion and the mitral valve prosthesis releasably attached thereto within the native mitral valve includes adjusting an extension angle formed between the arm portion and the delivery catheter.

15. The method of claim 14 , wherein adjusting the extension angle includes tensioning or relaxing a tether device attached to the arm portion.

16. The method of claim 1 , wherein the mitral valve prosthesis is self-expanding and deploying the mitral valve prosthesis includes release of a cinch device.

17. The method of claim 1 , wherein a balloon is attached to the arm portion of the articulation assembly.

18. The method of claim 17 , wherein the mitral valve prosthesis is balloon-expandable and deploying the mitral valve prosthesis includes expanding the balloon to expand the mitral valve prosthesis.

19. The method of claim 17 , wherein transitioning the articulation assembly from the closed state to the open state includes expanding the balloon.

20. The method of claim 1 , further comprising:
returning the articulation assembly to the closed state after deploying the mitral valve prosthesis; and
proximally retracting the delivery system for removal.

Assignees

• Medtronic Vascular Inc

Inventors

• O'Connell Barry
• Griffin Patrick
• Bateman Michael
• Haynes William

Classifications

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title

• A61F2/2433 Primary

  using balloon catheter · CPC title

• A61F2/2466

  Delivery devices therefor · CPC title